Regulatory Affairs & Quality Assurance Specialist (m/f/d)

About us

Today, 7 out of 10 people globally lack access to life-saving Magnetic Resonance Imaging (MRI). Conventional MRI machines are massive, cost millions of euros, and require specialized, shielded rooms which means they are usually confined to large hospitals.

At DeepSpin, we are changing that by building the World’s First Flatbed MRI.

Our open-architecture scanner plugs into a standard wall socket, fits into regular doctor's offices, and costs 10x less than conventional systems.

Backed by globally leading VCs, we are expanding our team in Berlin. This is an opportunity to join a mission-driven team bringing an essential medical technology to the billions of people who currently cannot afford it.

About Position

As our Regulatory Affairs & Quality Assurance Specialist, you will support the medical device certification for our MRI system in the US and Europe while helping maintain and improve our Quality Management System (QMS).

This is a high-impact, hands-on role where you will work closely with cross-functional teams to execute our regulatory strategy and play a vital role in bringing our technology to market.

Your Responsibilities:

• Certification Support: Coordinate and contribute to the preparation of CE Class IIa medical device certification and FDA 510(k) submission packages.
• Documentation: Draft, review, and maintain technical documentation for regulatory submissions, including Design History Files (DHF), Device Master Records (DMR), Risk Management Files, and usability data (IEC 62366).
• Compliance & Risk: Facilitate risk management activities according to ISO 14971, and help coordinate product testing for electromagnetic safety/compatibility, cybersecurity, and biocompatibility.
• QMS Maintenance: Maintain and continuously improve daily QMS processes in line with ISO 13485 and FDA 21 CFR 820 standards under the guidance of leadership.
• Gap Analysis & Collaboration: Assist with gap analyses to identify compliance improvements. Collaborate with engineering staff on design reviews, standard operating procedures (SOPs), work instructions, and V&V testing.

• External Liaison: Act as the primary contact and coordinate with notified bodies (TÜV, FDA, LaGeSo) and competent authorities.

• Post-Market & Infrastructure: Support post-market surveillance, vigilance, and complaint handling (ensuring timely reporting under 21 CFR 803). Help build a simplified, practical reporting infrastructure that satisfies regulatory needs.

Requirements

You are a proactive, detail-oriented regulatory professional who thrives in a collaborative team environment and is excited by the challenge of supporting a complex physical and digital product through commercialization.

What you bring:

• Education: A degree in Life Sciences, Engineering, or a related technical field.

• Experience: 3–5 years of hands-on regulatory experience in the medical device industry.

• Track Record: Proven success taking a Class II medical device through the FDA 510(k) or CE certification process.

• Standards & Testing: Solid working knowledge of ISO 13485 and ISO 14971, along with familiarity coordinating product safety testing (electromagnetic, cybersecurity, or biocompatibility).

• Relationship Management: Experience engaging and working directly with notified bodies and authorities.

• Communication: Clear written and verbal communication skills in English.

Nice-to-haves (Preferred):

• Training or experience as a Risk Manager (ISO 14971).

• Experience with clinical evaluations.

• A technical interest in how MRI technology works.

What we offer

• Compensation: A total package value of up to €110,000/year (consisting of an €70,000 - €80,000 base salary + benefits+ stock options).

• Culture: A creative, collaborative workplace with flat hierarchies and open communication.

• International Team: An English-first office with over 10 different nationalities driven by the same purpose.

• Perks: Work from our penthouse office, enjoy company-sponsored lunches, regular team events, and access to Urban Sports Club, BVG (public transport), and lifestyle vouchers.

• Development: High responsibility from day one, internal mentorship, and support for external training or certifications.

• Balance: 30 days of paid annual leave and flexible working hours.

• Relocation: Support with visas, relocation logistics, and help finding local daycare for your children.